Progesterone Combinations

Abstract

The present disclosure describes a method for treating or preventing an inflammatory ocular surface disease or disorder, such as ocular graft-versus-host disease, dry eye, meibomian gland disease, thyroid eye disease, blepharitis, Sjogren's syndrome, peripheral ulcerative keratitis, or Stevens-Johnson syndrome, in a human subject in need thereof, the method comprising (a) administering a topical progesterone composition to the forehead of the subject; (b) administering punctal plugs to the subject; and (c) administering a opical corticosteroid composition, such as loteprednol etabonate ointment, to the eye of the subject. Such administration methods may also be useful in improving corneal health before cataract surgery and/or promoting healing of the cornea after cataract surgery.

What is claimed is: 
     
         1 . A method for treating or preventing an inflammatory ocular disease or condition in a human subject in need thereof, the method comprising:
 (a) administering a topical progesterone composition to the forehead of the subject;   (b) administering punctal plugs to the subject; and   (c) administering a topical corticosteroid composition to the eye of the subject.   
     
     
         2 . The method of  claim 1 , wherein the inflammatory ocular disease or condition comprises ocular graft-versus-host disease, dry eye, meibomian gland disease, thyroid eye disease, blepharitis, Sjogren's syndrome, peripheral ulcerative keratitis, or Stevens-Johnson syndrome. 
     
     
         3 . The method of  claim 1 , wherein the inflammatory ocular disease or condition is ocular graft-versus-host disease. 
     
     
         4 . A method for improving corneal health before cataract surgery and/or promoting healing of the cornea after cataract surgery in a human subject in need thereof, the method comprising:
 (a) administering a topical progesterone composition to the forehead of the subject;   (b) administering punctal plugs to the subject; and   (c) administering a topical corticosteroid composition to the eye of the subject.   
     
     
         5 . The method of any one of  claims 1  to  4 , wherein the corticosteroid comprises a low to medium strength corticosteroid. 
     
     
         6 . The method of any one of  claims 1  to  5 , wherein the corticosteroid comprises loteprednol etabonate, betamethasone, dexamethasone, difluprednate, prednisolone, triamcinolone, rimexolone, or fluorometholone. 
     
     
         7 . The method of any one of  claims 1  to  6 , wherein the corticosteroid is formulated in a gel or an ointment. 
     
     
         8 . A method for treating ocular graft-versus-host disease in a human subject in need thereof, the method comprising:
 (a) administering a topical progesterone composition to the forehead of the subject;   (b) administering punctal plugs to the subject; and   (c) administering a topical loteprednol etabonate ointment composition to the eye of the subject.   
     
     
         9 . The method of any one of  claims 1  to  8 , wherein the progesterone composition comprises from 0.01% to 10% progesterone by weight. 
     
     
         10 . The method of any one of  claims 1  to  8 , wherein the progesterone composition comprises from 0.1% to 5% progesterone by weight. 
     
     
         11 . The method of any one of  claims 8 - 10 , comprising twice daily or once daily administration of the progesterone composition. 
     
     
         12 . The method of any one of  claims 8 - 11 , comprising administering from 0.01 mg to 10 mg progesterone daily. 
     
     
         13 . The method of any one of  claims 1  to  12 , wherein the corticosteroid composition comprises from 0.05% to 1% corticosteroid. 
     
     
         14 . The method of any one of  claims 1  to  13 , comprising once daily administration of the corticosteroid composition. 
     
     
         15 . The method of any one of  claims 1  to  14 , wherein the method further comprises administration of at least one additional therapy. 
     
     
         16 . A method for treating ocular graft-versus-host disease in a human subject in need thereof, the method comprising:
 (a) administering a topical 1% progesterone composition to the forehead of the subject twice daily;   (b) administering punctal plugs to the subject; and   (c) administering a topical 0.5% loteprednol etabonate ointment composition to the eye of the subject once daily.   
     
     
         17 . Use of progesterone in the manufacture of a topical medicament for administration to the forehead of a human subject in treating or preventing an inflammatory ocular disease or condition in the subject, wherein the use further comprises administration of punctal plugs and a topical corticosteroid composition to the eye of the subject. 
     
     
         18 . Use of progesterone in the manufacture of a topical medicament for administration to the forehead of a human subject in improving corneal health before cataract surgery and/or promoting healing of the cornea after cataract surgery in the subject, wherein the use further comprises administration of punctal plugs and a topical corticosteroid composition to the eye of the subject. 
     
     
         19 . Use of progesterone in the manufacture of a topical medicament for administration to the forehead of a human subject in treating ocular graft-versus-host disease in the subject, wherein the use further comprises administration of punctal plugs and a topical corticosteroid loteprednol etabonate ointment composition to the eye of the subject. 
     
     
         20 . A topical composition of progesterone for use in treating or preventing an inflammatory ocular disease or condition in a human subject, wherein the composition is to be administered in conjunction with punctal plugs and a topical corticosteroid composition to the eye of the subject. 
     
     
         21 . A topical composition of progesterone for use in improving corneal health before cataract surgery and/or promoting healing of the cornea after cataract surgery in a human subject, wherein the composition is to be administered in conjunction with punctal plugs and a topical corticosteroid composition to the eye of the subject. 
     
     
         22 . A topical composition of progesterone for use in treating ocular graft-versus-host disease in a human subject, wherein the composition is to be administered in conjunction with punctal plugs and a topical corticosteroid loteprednol etabonate ointment composition to the eye of the subject.